Transitions of care for older adults discharged home from the emergency department: an inductive thematic content analysis of patient comments.

OBJECTIVE: Improving care transitions for older adults can reduce emergency department (ED) visits, adverse events, and empower community autonomy. We conducted an inductive qualitative content analysis to identify themes emerging from comments to better understand ED care transitions. METHODS: The LEARNING WISDOM prospective longitudinal observational cohort includes older adults (≥ 65 years) who experienced a care transition after an ED visit from both before and during COVID-19. Their comments on this transition were collected via phone interview and transcribed. We conducted an inductive qualitative content analysis with randomly selected comments until saturation. Themes that arose from comments were coded and organized into frequencies and proportions. We followed the Standards for Reporting Qualitative Research (SRQR). RESULTS: Comments from 690 patients (339 pre-COVID, 351 during COVID) composed of 351 women (50.9%) and 339 men (49.1%) were analyzed. Patients were satisfied with acute emergency care, and the proportion of patients with positive acute care experiences increased with the COVID-19 pandemic. Negative patient comments were most often related to communication between health providers across the care continuum and the professionalism of personnel in the ED. Comments concerning home care became more neutral with the COVID-19 pandemic. CONCLUSION: Patients were satisfied overall with acute care but reported gaps in professionalism and follow-up communication between providers. Comments may have changed in tone from positive to neutral regarding home care over the COVID-19 pandemic due to service slowdowns. Addressing these concerns may improve the quality of care transitions and provide future pandemic mitigation strategies.

Scoping review of rehabilitation care models for post COVID-19 condition.

Objective: To systematically map the current evidence about the characteristics of health systems, providers and patients to design rehabilitation care for post coronavirus disease 2019 (COVID-19) condition. Methods: We conducted a scoping review by searching the databases: MEDLINE®, Embase®, Web of Science, Cochrane COVID-19 Registry and Cochrane Central Register of Controlled Trials, from inception to 22 April 2022. The search strategy included terms related to (i) post COVID-19 condition and other currently known terminologies; (ii) care models and pathways; and (iii) rehabilitation. We applied no language or study design restrictions. Two pairs of researchers independently screened title, abstracts and full-text articles and extracted data. We charted the evidence according to five topics: (i) care model components and functions; (ii) safe delivery of rehabilitation; (iii) referral principles; (iv) service delivery settings; and (v) health-care professionals. Findings: We screened 13 753 titles and abstracts, read 154 full-text articles, and included 37 articles. The current evidence is conceptual and expert based. Care model components included multidisciplinary teams, continuity or coordination of care, people-centred care and shared decision-making between clinicians and patients. Care model functions included standardized symptoms assessment, telehealth and virtual care and follow-up system. Rehabilitation services were integrated at all levels of a health system from primary care to tertiary hospital-based care. Health-care workers delivering services within a multidisciplinary team included mostly physiotherapists, occupational therapists and psychologists. Conclusion: Key policy messages include implementing a multilevel and multiprofessional model; leveraging country health systems' strengths and learning from other conditions; financing rehabilitation research providing standardized outcomes; and guidance to increase patient safety.

Development and Pilot Testing of Decision Aid for Shared Decision Making in Barrett's Esophagus With Low-Grade Dysplasia.

GOALS: To develop an encounter decision aid [Barrett's esophagus Choice (BE-Choice)] for patients and clinicians to engage in shared decision making (SDM) for management of BE with low-grade dysplasia (BE-LGD) and assess its impact on patient-important outcomes. BACKGROUND: Currently, there are 2 strategies for management of BE-LGD-endoscopic surveillance and ablation. SDM can help patients decide on their preferred management option. STUDY: Phase-I: Patients and clinicians were engaged in a user-centered design approach to develop BE-Choice. Phase-I included review of evidence on BE-LGD management, observation of usual care (UC), creation, field-testing, and iterative development of BE-Choice in clinical settings. Phase-II: Impact of BE-Choice on patient-important outcomes (patient knowledge, decisional conflict, and patient involvement in decision making) was assessed using a controlled before-after study design (UC vs. BE-Choice). RESULTS: Phase-I: Initial prototype was designed with observation of 8 clinical encounters. With field-testing, 3 successive iterations were made before finalizing BE-Choice. BE-Choice was paper based and fulfilled the qualifying criteria of International patient decision aid standards. Phase II: 29 patients were enrolled, 8 to UC and 21 to BE-Choice. Compared with UC, use of BE-Choice improved patient knowledge (90.4% vs. 70.5%; P=0.03), decisional comfort (89.6 vs. 71.9; P=0.01), and patient involvement (OPTION score: 27.1 vs. 19.2; P=0.01). CONCLUSIONS: BE-Choice is a feasible and effective decision aid to promote SDM in the management of BE-LGD. On pilot testing, BE-Choice had promising impact on patient-important outcomes. A larger multicenter trial is needed to confirm our results and promote widespread use of BE-Choice.

Randomized comparison of a reduced-visit prenatal care model enhanced with remote monitoring.

BACKGROUND: Standard prenatal care, consisting of 12-14 visits per pregnancy, is expensive and resource intensive, with limited evidence supporting the structure, rhythm, or components of care. Some studies suggest a reduced-frequency prenatal care model is as safe as the standard model of care for low-risk pregnant women, but evidence is limited. We developed and evaluated an innovative, technology-enhanced, reduced prenatal visit model (OB Nest). OBJECTIVE: To evaluate the acceptability and effectiveness of OB Nest, a reduced-frequency prenatal care model enhanced with remote home monitoring devices and nursing support. STUDY DESIGN: A single-center randomized controlled trial, composed of pregnant women, aged 18-36 years, recruited from an outpatient obstetric tertiary academic center in the Midwest United States. OB Nest care consisted of 8 onsite appointments with an obstetric provider; 6 virtual visits consisting of phone or online communication with an assigned nurse, supplemented with fetal Doppler and sphygmomanometer home monitoring devices; and access to an online community of pregnant women. Usual care consisted of 12 prescheduled prenatal clinic appointments with obstetric providers. Acceptability of OB Nest was measured by validated surveys of patient satisfaction with care at 36 weeks; perception of stress at 14, 24, and 36 weeks; and perceived quality of care at 36 weeks of gestation. Effectiveness was analyzed by comparing adherence to the American College of Obstetricians and Gynecologists recommended routine prenatal and ancillary services, maternal and fetal safety outcomes, and healthcare utilization. RESULTS: Three hundred pregnant women at <13 weeks of gestation were recruited and randomized to OB Nest or usual care (150 in each arm) using a minimization algorithm. Demographic characteristics were similar between groups. Compared to usual care, patients in OB Nest had higher satisfaction on a 100-point validated modified Littlefield and Adams Satisfaction scale (OB Nest = 93.9% vs usual care = 78.9%, P < .01). Pregnancy-related stress, measured, on a 0-2 point PreNatal Maternal Stress validated scale, with higher scores indicating higher levels of stress, was lower among OB Nest participants at 14 weeks (OB Nest = 0.32 vs usual care = 0.41, P < .01) and at 36 weeks of gestation (OB Nest = 0.34 vs usual care = 0.40, P < .03). There was no statistical difference in perceived quality of care. Adherence to the provision of American College of Obstetricians and Gynecologists prenatal services was similar in both arms. Maternal and fetal clinical outcomes were similar between groups. Total reported nursing time was higher in OB Nest (OB Nest = 171.2 minutes vs usual care = 108.2 minutes, 95% confidence interval, 48.7-77.4). CONCLUSION: OB Nest is an innovative, acceptable, and effective reduced-frequency prenatal care model. Compared to routine prenatal care, OB Nest resulted in higher patient satisfaction and lower prenatal stress, while reducing the number of appointments with clinicians and maintaining care standards for pregnant women. This program is a step toward evidence-driven prenatal care that improves patient satisfaction.

Does gender bias in cardiac stress testing still exist? A videographic analysis nested in a randomized controlled trial.

OBJECTIVES: Despite a high prevalence of coronary heart disease in both genders, studies show a gender disparity in evaluation whereby women are less likely than men to undergo timely or comprehensive cardiac investigation. Using videographic analysis, we sought to quantify gender differences in provider recommendations and patient evaluations. METHODS: We analyzed video recordings from our Chest Pain Choice trial, a single center patient-level randomized trial in which emergency department patients with chest pain being considered for cardiac stress testing were randomized to shared decision-making or usual care. Patient-provider interactions were video recorded. We compared characteristics and outcomes by gender. RESULTS: Of the 204 patients enrolled (101 decision aid; 103 usual care), 120 (58.8%) were female. Of the 75 providers evaluated, 20 (26.7%) were female. The mean (SD) pretest probability of acute coronary syndrome was lower in women [3.7% (2.2) vs 6.7% (4.4), P=.0002]. There was no gender effect on duration of discussion, clinician recommendations, OPTION scores, patient perceptions, or eventual patient dispositions. When the clinician and patient gender matched, OPTION scores were lower (interaction P=.002), and patients were less likely to find the information to be very helpful (interaction P=.10). CONCLUSIONS: Despite a lower pretest probability of acute coronary syndrome in women, we did not observe any significant gender disparity in how patients were managed and evaluated. When the patients' and providers' gender matched, the provider involved them less in the decision making process, and the information provided was less helpful than when the genders did not match.

Non-pharmacological treatment of depression: a systematic review and evidence map.

BACKGROUND: The comparative effectiveness of non-pharmacological treatments of depression remains unclear. METHODS: We conducted an overview of systematic reviews to identify randomised controlled trials (RCTs) that compared the efficacy and adverse effects of non-pharmacological treatments of depression. We searched multiple electronic databases through February 2016 without language restrictions. Pairs of reviewers determined eligibility, extracted data and assessed risk of bias. Meta-analyses were conducted when appropriate. RESULT: We included 367 RCTs enrolling ∼20 000 patients treated with 11 treatments leading to 17 unique head-to-head comparisons. Cognitive behavioural therapy, naturopathic therapy, biological interventions and physical activity interventions reduced depression severity as measured using standardised scales. However, the relative efficacy among these non-pharmacological interventions was lacking. The effect of these interventions on clinical response and remission was unclear. Adverse events were lower than antidepressants. LIMITATION: The quality of evidence was low to moderate due to inconsistency and unclear or high risk of bias, limiting our confidence in findings. CONCLUSIONS: Non-pharmacological therapies of depression reduce depression symptoms and should be considered along with antidepressant therapy for the treatment of mild-to-severe depression. A shared decision-making approach is needed to choose between non-pharmacological therapies based on values, preferences, clinical and social context.

Decision Aid for Cigarette Smokers Scheduled for Elective Surgery.

BACKGROUND: Decision aids can increase patient involvement in decision-making about health care. The study goal was to develop and test a decision aid for use by clinicians in discussion options for changing smoking behavior before and after elective surgery. METHODS: In formative work, a decision aid was designed to facilitate patient-clinician discussion regarding three options: continue smoking, attempt a period of temporary abstinence, and attempt to quit smoking for good. A randomized, two-group pilot study was then conducted in smokers evaluated in preparation for elective surgery in a preoperative clinic to test the hypothesis that the decision aid would improve measures of decisional quality compared with usual care. RESULTS: The final decision aid consisted of three laminated cards. The front of each card included a colorful graphic describing each choice; the reverse including two to three pros and cons for each decision, a simple graphic illustrating the effects of smoking on the body, and a motivational phrase. In the randomized trial of 130 patients, the decision aid significantly (P < 0.05) improved measures of decisional quality and patient involvement in decision making (Cohen's d effect sizes of 0.76 and 1.20 for the Decisional Conflict Scale and Observing PatienT involvement In decisiON-making scale, respectively). However, the decision aid did not affect any aspect of perioperative smoking behavior, including the distribution of or adherence to choices. CONCLUSIONS: Although the use of a decision aid to facilitate clinician-patient discussions regarding tobacco use around the time of surgery substantially improved measures of decisional quality, it alone did not change perioperative tobacco use behavior.

Implementation of a new prenatal care model to reduce office visits and increase connectivity and continuity of care: protocol for a mixed-methods study.

BACKGROUND: Most low-risk pregnant women receive the standard model of prenatal care with frequent office visits. Research suggests that a reduced schedule of visits among low-risk women could be implemented without increasing adverse maternal or fetal outcomes, but patient satisfaction with these models varies. We aim to determine the effectiveness and feasibility of a new prenatal care model (OB Nest) that enhances a reduced visit model by adding virtual connections that improve continuity of care and patient-directed access to care. METHODS AND DESIGN: This mixed-methods study uses a hybrid effectiveness-implementation design in a single center randomized controlled trial (RCT). Embedding process evaluation in an experimental design like an RCT allows researchers to answer both "Did it work?" and "How or why did it work (or not work)?" when studying complex interventions, as well as providing knowledge for translation into practice after the study. The RE-AIM framework was used to ensure attention to evaluating program components in terms of sustainable adoption and implementation. Low-risk patients recruited from the Obstetrics Division at Mayo Clinic (Rochester, MN) will be randomized to OB Nest or usual care. OB Nest patients will be assigned to a dedicated nursing team, scheduled for 8 pre-planned office visits with a physician or midwife and 6 telephone or online nurse visits (compared to 12 pre-planned physician or midwife office visits in the usual care group), and provided fetal heart rate and blood pressure home monitoring equipment and information on joining an online care community. Quantitative methods will include patient surveys and medical record abstraction. The primary quantitative outcome is patient-reported satisfaction. Other outcomes include fidelity to items on the American Congress of Obstetricians and Gynecologists standards of care list, health care utilization (e.g. numbers of antenatal office visits), and maternal and fetal outcomes (e.g. gestational age at delivery), as well as validated patient-reported measures of pregnancy-related stress and perceived quality of care. Quantitative analysis will be performed according to the intention to treat principle. Qualitative methods will include interviews and focus groups with providers, staff, and patients, and will explore satisfaction, intervention adoption, and implementation feasibility. We will use methods of qualitative thematic analysis at three stages. Mixed methods analysis will involve the use of qualitative data to lend insight to quantitative findings. DISCUSSION: This study will make important contributions to the literature on reduced visit models by evaluating a novel prenatal care model with components to increase patient connectedness (even with fewer pre-scheduled office visits), as demonstrated on a range of patient-important outcomes. The use of a hybrid effectiveness-implementation approach, as well as attention to patient and provider perspectives on program components and implementation, may uncover important information that can inform long-term feasibility and potentially speed future translation. TRIAL REGISTRATION: Trial registration identifier: NCT02082275 Submitted: March 6, 2014.

Assessments of the extent to which health-care providers involve patients in decision making: a systematic review of studies using the OPTION instrument.

BACKGROUND: We have no clear overview of the extent to which health-care providers involve patients in the decision-making process during consultations. The Observing Patient Involvement in Decision Making instrument (OPTION) was designed to assess this. OBJECTIVE: To systematically review studies that used the OPTION instrument to observe the extent to which health-care providers involve patients in decision making across a range of clinical contexts, including different health professions and lengths of consultation. SEARCH STRATEGY: We conducted online literature searches in multiple databases (2001-12) and gathered further data through networking. INCLUSION CRITERIA: (i) OPTION scores as reported outcomes and (ii) health-care providers and patients as study participants. For analysis, we only included studies using the revised scale. DATA EXTRACTION: Extracted data included: (i) study and participant characteristics and (ii) OPTION outcomes (scores, statistical associations and reported psychometric results). We also assessed the quality of OPTION outcomes reporting. MAIN RESULTS: We found 33 eligible studies, 29 of which used the revised scale. Overall, we found low levels of patient-involving behaviours: in cases where no intervention was used to implement shared decision making (SDM), the mean OPTION score was 23 ± 14 (0-100 scale). When assessed, the variables most consistently associated with higher OPTION scores were interventions to implement SDM (n = 8/9) and duration of consultations (n = 8/15). CONCLUSIONS: Whatever the clinical context, few health-care providers consistently attempt to facilitate patient involvement, and even fewer adjust care to patient preferences. However, both SDM interventions and longer consultations could improve this.

Women's values in contraceptive choice: a systematic review of relevant attributes included in decision aids.

BACKGROUND: Women can choose from a range of contraceptive methods that differ in important ways. Inadequate decision support may lead them to select a method that poorly fits their circumstances, leading to dissatisfaction, misuse, or nonuse. Decision support interventions, such as decision aids, may help women choose a method of contraception that best fits their personal circumstances. To guide future decision aid development, we aim to summarize the attributes of contraceptive methods included in available decision aids as well as surveys and interviews of women actively choosing a contraceptive method. METHODS: We conducted a systematic review to identify attributes of contraceptive methods that may be important to women when engaging in this decision making process. We performed a database search of MEDLINE/PubMed, Ovid EMBASE, OVID CENTRAL, Ovid PsycInfo, EBSCO CINAHL, Popline, and Scopus from 1985 until 2013 to identify decision aids, structured interviews and questionnaires reporting attributes of contraceptive options that are of importance to women. A free-text internet search was also performed to identify additional decision support tools. All articles and tools were reviewed in duplicate for inclusion, and a summary list of attributes was compiled. RESULTS: We included 20 surveys, 1 semistructured interview report and 19 decision aids, reporting 32 unique attributes. While some attributes were consistently included in surveys/interviews and decision aids, several were included more often in decision aids as opposed to surveys/interviews (e.g., STI prevention, noncontraceptive benefits, how the method is used, requirement of a healthcare provider), and vice versa (e.g., a woman's vicarious experience with contraceptive methods). Key attributes mentioned in both surveys/interviews and decision aids include efficacy (29 total mentioned) and side effects/health risks (28 total mentioned). While a limited number of decision support tools were formally evaluated, many were not rigorously studied. CONCLUSIONS: Many attributes were identified as potentially important to women choosing a method of contraception, but these were inconsistently included in the reviewed resources. Formal evaluation of decision support tools for contraceptive choice and involvement of users in the development process may lead to more user-centered design and implementation.

Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis.

BACKGROUND: Gender differences in communication styles between clinicians and patients have been postulated to impact patient care, but the extent to which the gender dyad structure impacts outcomes in shared decision making remains unclear. METHODS: Participant-level meta-analysis of 775 clinical encounters within 7 randomized trials where decision aids, shared decision making tools, were used at the point of care. Outcomes analysed include decisional conflict scale scores, satisfaction with the clinical encounter, concordance between stated decision and action taken, and degree of patient engagement by the clinician using the OPTION scale. An estimated minimal important difference was used to determine if nonsignificant results could be explained by low power. RESULTS: We did not find a statistically significant interaction between clinician/patient gender mix and arm for decisional conflict, satisfaction with the clinical encounter or patient engagement. A borderline significant interaction (p = 0.05) was observed for one outcome: concordance between stated decision and action taken, where encounters with female clinician/male patient showed increased concordance in the decision aid arm compared to control (8% more concordant encounters). All other gender dyads showed decreased concordance with decision aid use (6% fewer concordant encounters for same-gender, 16% fewer concordant encounters for male clinician/female patient). CONCLUSIONS: In this participant-level meta-analysis of 7 randomized trials, decision aids used at the point of care demonstrated comparable efficacy across gender dyads. Purported barriers to shared decision making based on gender were not detected when tested for a minimum detected difference. TRIAL REGISTRATIONS: ClinicalTrials.gov NCT00888537, NCT01077037, NCT01029288, NCT00388050, NCT00578981, NCT00949611, NCT00217061.

Assessing the Feasibility and Preliminary Effects of a Web-Based Self-Management Program for Chronic Noncancer Pain: Mixed Methods Study.

BACKGROUND: In Canada, adults with chronic noncancer pain face a persistent insufficiency of publicly funded resources, with the gold standard multidisciplinary pain treatment facilities unable to meet the high clinical demand. Web-based self-management programs cost-effectively increase access to pain management and can improve several aspects of physical and emotional functioning. Aiming to meet the demand for accessible, fully automated resources for individuals with chronic noncancer pain, we developed a French web- and evidence-based self-management program, Agir pour moi (APM). This program includes pain education and strategies to reduce stress, practice mindfulness, apply pacing, engage in physical activity, identify and manage thinking traps, sleep better, adapt diet, and sustain behavior change. OBJECTIVE: This study aims to assess the APM self-management program's feasibility, acceptability, and preliminary effects in adults awaiting specialized services from a center of expertise in chronic pain management. METHODS: We conducted a mixed methods study with an explanatory sequential design, including a web-based 1-arm trial and qualitative semistructured interviews. We present the results from both phases through integrative tables called joint displays. RESULTS: Response rates were 70% (44/63) at postintervention and 56% (35/63) at 3-month follow-up among the 63 consenting participants who provided self-assessed information at baseline. In total, 46% (29/63) of the participants completed the program. We interviewed 24% (15/63) of the participants. The interview's first theme revolved around the overall acceptance, user-friendliness, and engaging nature of the program. The second theme emphasized the differentiation between microlevel and macrolevel engagements. The third theme delved into the diverse effects observed, potentially influenced by the macrolevel engagements. Participants highlighted the features that impacted their self-efficacy and the adoption of self-management strategies. We observed indications of improvement in self-efficacy, pain intensity, pain interference, depression, and catastrophizing. Interviewees described these and various other effects as potentially influenced by macrolevel engagement through behavioral change. CONCLUSIONS: These findings provided preliminary evidence that the APM self-management program and research methods are feasible. However, some participants expressed the need for at least phone reminders and minimal support from a professional available to answer questions over the first few weeks of the program to engage. Recruitment strategies of a future randomized controlled trial should focus on attracting a broader representation of individuals with chronic pain in terms of gender and ethnicity. TRIAL REGISTRATION: ClinicalTrials.gov NCT05319652; https://clinicaltrials.gov/study/NCT05319652.

Motivation to participate and attrition factors in a COVID-19 biobank: A qualitative study.

BACKGROUND: The Biobanque québécoise de la COVID-19 (Quebec Biobank for COVID-19, or BQC19) is a provincial initiative that aims to manage the longitudinal collection, storage, and sharing of biological samples and clinical data related to COVID-19. During the study, BQC19 investigators reported a high loss-to-follow-up rate. The current study aimed to explore motivational and attrition factors from the perspective of BQC19 participants and health care and research professionals. METHODS: This was an inductive exploratory qualitative study. Using a theoretical sampling approach, a sample of BQC19 participants and professionals were invited to participate via semi-structured interviews. Topics included motivations to participate; participants' fears, doubts, and barriers to participation; and professionals' experiences with biobanking during the COVID-19 pandemic. RESULTS: Interviews were conducted with BQC19 participants (n = 23) and professionals (n = 17) from 8 clinical data collection sites. Motivations included the contribution to science and society in crisis, self-worth, and interactions with medical professionals. Reasons for attrition included logistical barriers, negative attitudes about public health measures or genomic studies, fear of clinical settings, and a desire to move on from COVID-19. Motivations and barriers seemed to evolve over time and with COVID-19 trends and surges. Certain situations were associated with attrition, such as when patients experienced indirect verbal consent during hospitalization. Barriers related to human and material resources and containment/prevention measures limited the ability of research teams to recruit and retain participants, especially in the ever-evolving context of crisis. CONCLUSION: The pandemic setting impacted participation and attrition, either by influencing participants' motivations and barriers or by affecting research teams' ability to recruit and retain participants. Longitudinal and/or biobanking studies in a public health crisis setting should consider these factors to limit attrition.

The effects of antipsychotic discontinuation or maintenance on the process of recovery in remitted first-episode psychosis patients - A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The optimal duration of antipsychotic treatment following remission of first-episode psychosis (FEP) is uncertain, considering potential adverse effects and individual variability in relapse rates. This study aimed to investigate the effect of antipsychotic discontinuation compared to continuation on recovery in remitted FEP patients. METHODS: CENTRAL, MEDLINE (Ovid), Embase, and PsycINFO databases were searched on November 2, 2023, with no language restrictions. RCTs evaluating antipsychotic discontinuation in remitted FEP patients were selected. The primary outcome was personal recovery, and secondary outcomes included functional recovery, global functioning, hospital admission, symptom severity, quality of life, side effects, and employment. Risk of bias was assessed using the Cochrane risk-of-bias tool 2, and the certainty of evidence was evaluated with GRADE. Meta-analysis used a random-effect model with an inverse-variance approach. RESULTS: Among 2185 screened studies, 8 RCTs (560 participants) were included. No RCTs reported personal recovery as an outcome. Two studies measured functional recovery, and discontinuation group patients were more likely to achieve functional recovery (RR 2.19; 95% CIs: 1.13, 4.22; I2 = 0%; n = 128), although evidence certainty was very low. No significant differences were found in hospital admission, symptom severity, quality of life, global functioning, or employment between the discontinuation and continuation groups. CONCLUSIONS: Personal recovery was not reported in any antipsychotic discontinuation trial in remitted FEP. The observed positive effect of discontinuation on functional recovery came from an early terminated trial and an RCT followed by an uncontrolled period. These findings should be interpreted cautiously due to very low certainty of evidence.

Methods used to account for caregivers' sex and gender within studies examining the financial burden of caregivers of children and adolescents : Results from a scoping review.

Background: Interest in the financial burden of informal caregivers has been growing. Unfortunately, it remains unclear which method(s) should be used when quantifying this burden. Purpose: We conducted a scoping review aimed at identifying which methods have been used to conduct such work and quantified their performance. We were also interested in examining how sex and gender considerations were considered within selected studies. Data Sources: Using a standardized approach, we identified studies published between 2012 and 2022 that aimed to document the financial burden of caregivers to child and adolescent patients. Our search strategy was applied to the MEDLINE, Embase, CINHAL, and Academic Search Premier databases. Study Selection: Manuscript selection was performed by pairs of reviewers. Data Extraction: Data extraction was performed by one reviewer with a second reviewer performing quality control. Results were reported using a narrative approach. Data Synthesis: We identified 9801 unique citations, of which 200 were included in our review. Selected studies covered various disease area (eg, infection/parasitic diseases [n = 31, 16%]) and included quantitative (n = 180, 90%), qualitative (n = 4, 2%) and mixed study designs (n = 16, 8%). Most studies (n = 182, 91%) used questionnaires/surveys, either alone or in combination with other methods, to assess caregivers' financial burden. Less than half (n = 93, 47%) of studies reported on caregivers' sex and none reported on their gender. Conclusion: We conducted an unrestricted review of published studies examining caregiver's financial burden which allowed us to identify general methodological trends observed in this literature. We believe this work may help improve future studies focusing on this important issue.

OMERACT Core outcome measurement set for shared decision making in rheumatic and musculoskeletal conditions: a scoping review to identify candidate instruments.

OBJECTIVES: Shared decision making (SDM) is a central tenet in rheumatic and musculoskeletal care. The lack of standardization regarding SDM instruments and outcomes in clinical trials threatens the comparative effectiveness of interventions. The Outcome Measures in Rheumatology (OMERACT) SDM Working Group is developing a Core Outcome Set for trials of SDM interventions in rheumatology and musculoskeletal health. The working group reached consensus on a Core Outcome Domain Set in 2020. The next step is to develop a Core Outcome Measurement Set through the OMERACT Filter 2.2. METHODS: We conducted a scoping review (PRISMA-ScR) to identify candidate instruments for the OMERACT Filter 2.2 We systematically reviewed five databases (Ovid MEDLINE®, Embase, Cochrane Library, CINAHL and Web of Science). An information specialist designed search strategies to identify all measurement instruments used in SDM studies in adults or children living with rheumatic or musculoskeletal diseases or their important others. Paired reviewers independently screened titles, abstracts, and full text articles. We extracted characteristics of all candidate instruments (e.g., measured construct, measurement properties). We classified candidate instruments and summarized evidence gaps with an adapted version of the Summary of Measurement Properties (SOMP) table. RESULTS: We found 14,464 citations, read 239 full text articles, and included 99 eligible studies. We identified 220 potential candidate instruments. The five most used measurement instruments were the Decisional Conflict Scale (traditional and low literacy versions) (n=38), the Hip/Knee-Decision Quality Instrument (n=20), the Decision Regret Scale (n=9), the Preparation for Decision Making Scale (n=8), and the CollaboRATE (n=8). Only 44 candidate instruments (20%) had any measurement properties reported by the included studies. Of these instruments, only 57% matched with at least one of the 7-criteria adapted SOMP table. CONCLUSION: We identified 220 candidate instruments used in the SDM literature amongst people with rheumatic and musculoskeletal diseases. Our classification of instruments showed evidence gaps and inconsistent reporting of measurement properties. The next steps for the OMERACT SDM Working Group are to match candidate instruments with Core Domains, assess feasibility and review validation studies of measurement instruments in rheumatic diseases or other conditions. Development and validation of new instruments may be required for some Core Domains.

Shared decision making for patients with type 2 diabetes: a randomized trial in primary care.

BACKGROUND: Patient-centered diabetes care requires shared decision making (SDM). Decision aids promote SDM, but their efficacy in nonacademic and rural primary care clinics is unclear. METHODS: We cluster-randomized 10 practices in a concealed fashion to implement either a decision aid (DA) about starting statins or one about choosing antihyperglycemic agents. Each practice served as a control group for another practice implementing the other type of DA. From April 2011 to July 2012, 103 (DA=53) patients with type 2 diabetes participated in the trial. We used patient and clinician surveys administered after the clinical encounter to collect decisional outcomes (patient knowledge and comfort with decision making, patient and clinician satisfaction). Medical records provided data on metabolic control. Pharmacy fill profiles provided data for estimating adherence to therapy. RESULTS: Compared to usual care, patients receiving the DA were more likely to report discussing medications (77% vs. 45%, p<.001), were more likely to answer knowledge questions correctly (risk reduction with statins 61% vs. 33%, p=.07; knowledge about options 57% vs. 33%, p=.002) and were more engaged by their clinicians in decision making (50. vs. 28, difference 21.4 (95% CI 6.4, 36.3), p=.01). We found no significant impact on patient satisfaction, medication starts, adherence or clinical outcomes, in part due to limited statistical power. CONCLUSION: DAs improved decisional outcomes without significant effect on clinical outcomes. DAs designed for point-of-care use with type 2 diabetes patients promoted shared decision making in nonacademic and rural primary care practices. TRIAL REGISTRATION: NCT01029288.

Basing information on comprehensive, critically appraised, and up-to-date syntheses of the scientific evidence: a quality dimension of the International Patient Decision Aid Standards.

BACKGROUND: Patients and clinicians expect patient decision aids to be based on the best available research evidence. Since 2005, this expectation has translated into a quality dimension of the International Patient Decision Aid Standards. METHODS: We reviewed the 2005 standards and the available literature on the evidence base of decision aids as well as searched for parallel activities in which evidence is brought to bear to inform clinical decisions. In conducting this work, we noted emerging and research issues that require attention and may inform this quality dimension in the future. RESULTS: This dimension requires patient decision aids to be based on research evidence about the relevant options and the nature and likelihood of their effect on outcomes that matter to patients. The synthesis of evidence should be comprehensive and up-to-date, and the evidence itself subject to critical appraisal. Ethical (informed patient choice), quality-of-care (patient-centered care), and scientific (evidence-based medicine) arguments justify this requirement. Empirical evidence suggests that over two thirds of available decision aids are based on high-quality evidence syntheses. Emerging issues identified include the duties of developers regarding the conduct of systematic reviews, the impact of comparative effectiveness research, their link with guidelines based on the same evidence, and how to present the developers' confidence in the estimates to the end-users. Systematic application of the GRADE system, common in contemporary practice guideline development, could enhance satisfaction of this dimension. CONCLUSIONS: While theoretical and practical issues remained to be addressed, high-quality patient decision aids should adhere to this dimension requiring they be based on comprehensive and up-to-date summaries of critically appraised evidence.

A Quality Assessment of Goals of Care Forms in a Sample of Older Patients in Various Care Settings in Quebec, Canada.

OBJECTIVE:  The objective of this study is to assess the completion and content of the Goals of Care (GOC) forms in three care settings in the province of Quebec, Canada. METHODS: This is a retrospective, cross-sectional, mixed methods analysis of data extracted from the charts and GOC forms of patients aged over 65 who received services during the year 2018 in one of the three following care settings: (i) long-term care facility, (ii) acute care hospital, and (iii) home support services of a regional healthcare and social services center. The completion of the GOC form includes six essential sections. If one or more of the sections were not fulfilled, we considered the form incomplete. We used descriptive analysis to look at the information in the six sections and a thematic analysis to assess the information in an open-ended section. RESULTS: We audited 589 charts, of which 67% contained a GOC form and only 96 (16%) a completed one. The most popular goal of care was ensuring comfort as a priority over prolonging life, selected on 40% of the forms. The majority of the included patients (89%) did not want cardiopulmonary resuscitation (CPR) to be attempted in the case of cardiac arrest. There was no indication of the use of advance medical directives, and scarce indication of the use of former GOC forms (18%) and living wills (2%) in completing the forms. Comments were included in 65% of the open-ended sections. The most frequent themes related to the use or non-use of interventions and to potential transfers to the hospital or to an intensive care unit. We found that the open-ended section was used on 24 forms to specify a different goal of care applicable in the event of further health deterioration. DISCUSSION AND CONCLUSIONS: A significant proportion of charts (84%) did not contain a completed GOC form; key aspects of advance care planning were rarely considered in establishing the patient's goal of care, and the form itself lacked utility given the frequency and nature of qualitative comments. As a final product of serious illness communication and decision-making, our findings suggest that there are significant quality issues, that patients are at risk of intensification of care at the end of life, and that more needs to be done to improve serious illness decision-making and documentation.